JPH082353B2 - Method of manufacturing blood collection tube for inspection - Google Patents

Description

TECHNICAL FIELD The present invention relates to a method for producing a test blood collection tube in which a blood or blood collecting tube contains a serum or plasma separating agent composed of a viscous fluid.

(Prior Art) When collecting a blood sample in a clinical test or other tests, a vacuum blood collection tube or a normal pressure blood collection tube containing a serum or plasma separating agent composed of a viscous fluid at the bottom of the blood collection tube or a so-called Spitz tube is used. Widely used.

Among these blood collection tubes for examination, a vacuum blood collection tube generally includes a step of injecting a serum or plasma separating agent composed of a viscous fluid into the bottom of the blood collection tube under normal pressure, and a decompression corresponding to a prescribed blood collection amount after this step. Below, it is manufactured through a step of hermetically inserting a stopper into the open end of the blood collection tube.

In addition, a normal pressure blood collection tube generally has a step of injecting a serum or plasma separating agent composed of a viscous fluid into the bottom of the blood collection tube under normal pressure, and a plug at the open end of the blood collection tube under normal pressure after this step. It is manufactured through a process of lightly inserting. The step of inserting the plug may be omitted.

The above serum or plasma separating agent is composed of a viscous fluid obtained by mixing a liquid polymer such as a silicone-based oligomer with a filler having a specific gravity adjustment such as fine powder silica and thixotropic thickening, and its viscosity is usually Has a thixotropic property, exceeding 10,000 cps at 25 ° C.

And, such a serum or plasma separating agent usually has an inner diameter of 7 to 1 from a tubular nozzle having an inner diameter of about 1 to 3 mm.
It is injected into the bottom of a blood collection tube having a length of about 5 mm and a length of about 70 to 100 mm under normal pressure, that is, under an atmosphere of normal pressure.

However, the serum or plasma separating agent squeezed out as filaments from the above-mentioned tubular nozzle accumulates on the bottom of the blood collection tube with the filaments bent, and air bubbles are inevitably caught. The air bubbles that have been once entrapped are not degassed and disappear because the serum or plasma separating agent has a high viscosity and has thixotropic properties.

Therefore, not only the appearance of the product blood collection tube is significantly impaired, but also the filler such as fine powder silica existing around the air bubbles is easily separated from the matrix, and the centrifugal separation operation at the time of use of the product blood collection tube causes There is a problem that the fragments are suspended in the supernatant serum or plasma, and various inconveniences occur in inspection analysis such as clogging of pipettes and nozzles of automatic analyzers.

In particular, in the case of a vacuum blood collection tube, even small air bubbles in the normal pressure state swell greatly due to depressurization, and foaming and scattering occur. Therefore, appearance defects and other inconveniences due to air bubbles are more remarkable than in the case of a normal pressure blood collection tube. .

(Problems to be Solved by the Invention) The present invention is intended to solve the above problems, and an object of the present invention is to remarkably reduce air bubbles in a serum or plasma separating agent composed of a viscous fluid injected into a blood collection tube. An object of the present invention is to provide a method of manufacturing a blood collection tube for an examination that can be reduced.

(Means for Solving the Problem) The method for producing a test blood collection tube according to the present invention comprises the steps of injecting a serum or plasma separating agent consisting of a viscous fluid into a blood collection tube under reduced pressure,
A step of returning to a pressure higher than this pressure is included, whereby the above object is achieved.

 Hereinafter, the method of the present invention will be described with reference to the drawings.

In FIG. 1, 10 is a blood collection tube, and a bottomed tube made of synthetic resin such as polyethylene terephthalate, polyacrylonitrile, polypropylene, polyethylene, polystyrene, ABS resin or hard glass is used. 11
Is the bottom of the blood collection tube, and 12 is the open end of the blood collection tube.

The blood collection tube 10 is vertically supported in the recess of the pedestal 20 and transferred. Then, it temporarily stops at a fixed position, where the lid plate 30 descends from above to the open end of the blood collection tube 10, and the inside of the blood collection tube 10 is sealed.

A tube-shaped nozzle 31 and an exhaust pipe 32 are attached to the cover plate 30, and when the cover plate 30 descends to the open end of the blood collection tube 10, the tip ends of the nozzle 31 and the exhaust pipe 32 are connected to the blood collection tube. Located inside 10. The other ends of the nozzle 31 and the exhaust pipe 32 are
Each of them is connected to an injection device for a serum or plasma separating agent and a vacuum pump (neither is shown).

By the operation of the vacuum pump, the air inside the blood collection tube 10 is exhausted from the exhaust pipe 32, and the inside of the blood collection tube 10 is depressurized to a desired decompression degree which is a pressure equal to or lower than the pressure of the atmosphere in the blood collection tube in the product. . And under this reduced pressure, serum or plasma separating agent
40 is extruded from the tip of the nozzle 31 and injected into the bottom of the blood collection tube 10.

As the serum or plasma separating agent 40, a silicone-based oligomer, an acrylic-based oligomer, an ester-based oligomer,
A mixture of a liquid polymer such as an olefin-based oligomer and a filler such as fine powder silica and fine powder clay which adjusts the specific gravity and thickens the thixotrope is used.

After the injection of the serum or plasma separating agent 40 is completed, the airtightness inside the blood collection tube 10 is opened by the leak valve 33, the lid plate 30 is lifted, and the tips of the nozzle 31 and the exhaust pipe 32 are also moved upward of the blood collection tube 10. Rejected. In this way, the inside of the blood collection tube 10 is returned to normal pressure. In this step, the bottom of the blood collection tube 10 may be heated to about 40 to 100 ° C.

After the above steps, the blood collection tube 10 into which the serum or plasma separating agent has been injected undergoes the same steps as those for manufacturing a normal test blood collection tube. For example, when manufacturing a vacuum blood collection tube, as shown in FIG. 2, the blood collection tube 10 supported by the pedestal 20 is lightly inserted with a plug 50 made of an elastic material such as butyl rubber at the open end thereof. In this state, it is transferred into the airtight box 60.

Then, the air inside the airtight box 60 is exhausted from the exhaust pipe 61 by the operation of a vacuum pump (not shown),
The inside of the blood collection tube 10 and the inside of the blood collection tube 10 are depressurized to a decompression degree determined according to the blood sampling amount. After that, the plug is airtightly inserted into the open end of the blood collection tube 10 by the pressing force of the pressing tool 62. Thus, a vacuum blood collection tube is manufactured.

When manufacturing a normal pressure blood collection tube,
Instead of the step of airtightly inserting the plug body 50 into the open end of the plug, the step of lightly inserting the plug body 50 into the open end of the blood collection tube 10 or the step of inserting the plug body 50 can be omitted. Manufactured.

Further, as shown in FIG. 3, a cross-section type lid plate 30 'equipped with a plurality of nozzles 31' and exhaust pipes 32 'is used,
The inside of the plurality of blood collection tubes 10 'can be depressurized.
In this case, a plurality of blood collection tubes 1 are provided with the entire space 70 'surrounded by the cross-section type lid plate 30' and the mount 20 'being depressurized.
Serum or plasma separating agent 40 'is injected at the bottom of 0'. Then, after that, the pressure is returned to normal pressure by the leak valve 33 '.

A plurality of blood collection tubes 10 'into which the serum or plasma separating agent 40' has been injected in this manner are manufactured simultaneously with a plurality of vacuum blood collection tubes or normal pressure blood collection tubes in the same process as described with reference to FIG. It

In the manufacturing process described above, after injecting the serum or plasma separating agent under reduced pressure, the pressure is returned to normal pressure which is higher than this pressure. After injecting the separating agent under reduced pressure between the airtight vacuums, the pressure in the same airtight space is then returned to a pressure higher than that pressure, and the blood collection tube is also placed in the same airtight space under a reduced pressure corresponding to the specified blood collection volume. It is also possible to insert the plug body in an airtight manner at the open end of the plug.

(Operation) In the method of the present invention, when the serum or plasma separating agent consisting of a viscous fluid is injected into the bottom of a blood collection tube under reduced pressure, the pressure inside the bubbles entrapped in the serum or plasma separating agent is also reduced. Then, after that, when the pressure is returned to a pressure higher than the atmospheric pressure at the time of injecting the serum or plasma separating agent, the bubbles are crushed and become small, and the bubbles of a visible size are significantly reduced.

(Example) Next, the Example and comparative example of this invention are shown.

Examples 1 to 5 Liquid silicone oil (polydimethylsiloxane) containing polyethylene terephthalate, polyacrylonitrile, and hard glass as a blood collection tube, and 4% by weight of finely divided silica as a serum separating agent.
(Specific gravity 1.05 at 25 ℃, viscosity 150,000 cps)
100 vacuum blood collection tubes were manufactured by the method described with reference to FIGS. The manufacturing conditions and each 100
About the vacuum blood collection tube of the book, the number of no visible bubbles, the number of bubbles of less than 0.5 mmφ, the number of bubbles of 0.5 mmφ or more, and the number of the serum separating agent attached to the tube wall due to foam scattering Was examined and the results are shown in Table 1.

Comparative Examples 1 and 2 100 vacuum blood collection tubes were produced in the same manner as in Example 1 and Example 5 except that the serum separating agent was injected into the bottom of the blood collection tubes under normal pressure. For each of the manufacturing conditions and 100 vacuum blood collection tubes, there are no visible bubbles, 0.5 mmφ bubbles, 0.5 mm
The number of bubbles having a diameter of φ or more and the number of serum separating agents attached to the tube wall due to foam scattering were examined, and the results are shown in Table 1.

Example 6 A blood collection tube made of hard glass was used as a blood collection tube, and a liquid butene oligomer (specific gravity 1.05 at 25 ° C., viscosity 300,000 cps at 25 ° C.) mixed with 4% by weight of fine powder silica was used as a serum separating agent. By the method described in FIGS. 1 and 2, 100 vacuum blood collection tubes were manufactured. Regarding the production conditions and 100 vacuum blood collection tubes, the number of cells with no visible bubbles, the number of bubbles with a diameter of less than 0.5 mmφ, the number of bubbles with a diameter of 0.5 mmφ or more, and serum to the tube wall due to air scattering The number of adhered separating agents was examined, and the results are shown in Table 1.

(Effects of the Invention) As described above, the method for producing a blood collection tube for inspection according to the present invention includes the steps of injecting a serum or plasma separating agent consisting of a viscous fluid under reduced pressure into a blood collecting tube, By including the step of returning to a pressure higher than the atmospheric pressure, the bubbles entrapped in the serum or plasma separating agent are crushed and reduced, and the bubbles of a visible size are significantly reduced.

Therefore, the test blood collection tube manufactured through the above steps not only has an excellent appearance, but also does not cause separation of the filler such as fine powder silica of the serum or plasma separating agent, which easily occurs around the bubbles. , With stable quality.

In particular, in the production of a vacuum blood collection tube that is produced through a sealing step with a stopper under reduced pressure after the above step, foaming or scattering of the serum or plasma separating agent due to the air bubbles does not occur during this depressurization. , The adhesion of droplets to the inner wall of the blood collection tube is prevented.

[Brief description of drawings]

1 to 3 are explanatory views of the method of the present invention. 10, 10 '... Blood collection tube, 30, 30' ... Lid plate, 31, 31 '... Nozzle, 32, 32' ... Exhaust pipe, 40, 40 '... Serum or plasma separating agent, 50 ... Stopper, 60 ... Airtight box, 62 ... Pressing tool.

Claims (1)

[Claims] 1. A method for producing a test blood collection tube, which comprises the steps of injecting a serum or plasma separating agent consisting of a viscous fluid into a blood collection tube under reduced pressure, and then returning the pressure to a pressure higher than this pressure.